Liver-PILP First-in-Man (PILP FiM)

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The purpose of this study is to determine whether the PILP-kit can be safely used, within specific performance parameters, to isolate and perfuse the liver with a chemotherapeutic drug for the treatment of patients with unresectable liver metastases.

Condition or disease

Intervention/treatment

Liver Metastases

Device: Liver-PILP kit

Detailed Description:

The objective of this Medical Device Study, is to demonstrate the feasibility of the liver PILP intervention.

The liver PILP intervention will be considered feasible if the procedure is demonstrated to be safe and the liver PILP kit performs according to specifications.

The Vena Cava Device (VCD): catheter based device to isolate and access hepatic outflow to vena cava by creating a closed chamber in vena cava at ostia of the hepatic veins while maintaining central vena cava blood flow from lower extremities to right atrium through reduced central lumen.

To demonstrate the feasibility of the liver PILP intervention. [ Time Frame: During intervention and up to 30 days post intervention ]

The liver PILP intervention will be considered feasible if the intervention is demonstrated to be safe and the PILP kit performs according to specifications related to localization, flow rates and retrieval of devices.

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